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NCT02012231 · ClinicalTrials.gov registry record · Phase 1
Phase I/IIa Study to Evaluate the Safety, PK, PD, and Preliminary Efficacy of PLX8394 in Patients With Advanced Cancers.
A Phase 1 study, sponsored by Fore Biotherapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT02012231 is a Phase 1 study that was terminated before completion, run by Fore Biotherapeutics. The registered enrollment target is 5 participants.
The verdict
NCT02012231, a Phase 1 study, was terminated before completion, sponsored by Fore Biotherapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
The study objective is to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered PLX8394 in patients with advanced solid tumors. An additional objective is to identify a Recommended Phase 2 (RP2D) for further evaluation in the Extension Cohorts (Phase IIa portion). The study objective of the Extension Cohorts (PART 2 portion) is to assess the objective tumor response and the PK, PD, and safety of PLX8394 when the RP2D is used in patients with advanced BRAF-mutated cancers.
Interventions
- DRUG PLX8394
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2014-02 |
| Est. Completion | 2015-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02012231
The ClinicalTrials.gov registry entry for NCT02012231 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fore Biotherapeutics, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PLX8394 is the first listed.
NCT02012231 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02012231 about?
NCT02012231 is a clinical study titled "Phase I/IIa Study to Evaluate the Safety, PK, PD, and Preliminary Efficacy of PLX8394 in Patients With Advanced Cancers.". The study objective is to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered PLX8394 in patients with advanced solid tumors. An additional objective is to identify a Recommended Phase 2 (RP2D) for further evaluation in the Extension Cohorts (Phase IIa portio...
What is the current status of trial NCT02012231?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2014-02. Estimated completion is 2015-06.
What interventions are being tested in trial NCT02012231?
The interventions under investigation include: PLX8394 (DRUG).
Who is sponsoring clinical trial NCT02012231?
This trial is sponsored by Fore Biotherapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
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